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UNITED
STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON,
D.C. 20460
SEP 27, 2001
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
Hawaii Department of Agriculture
P.O. Box 22159
Honolulu, Hawaii 96823-2159
Attention: Mr. Robert A. Boesch (shennanp@hgea.org)
Phone: 808-973-9404
Fax: 808-973-9418
File Symbol: 01-HI-03
Expiration: SEP
27 2002
Report Due: MAR
30 2003
The Environmental Protection Agency hereby grants
a specific exemption under the provisions of section 18
of the Federal Insecticide, Fungicide, and Rodenticide
Act, as amended, to the Hawaii Department of Agriculture
for the use of caffeine (1,3,7-trimethylxanthine) on
floriculture and nursery crops, outdoor ornamental
plants in residential areas, parks, hotels and resorts,
and forest habitats to control coqui (Eleutherodactylus
coqui) and greenhouse (E. planirostris) frogs. This
specific exemption is subject to the conditions and
restrictions set forth in your application except as
superceded by this document, as follows:
1.
The Hawaii Department of Agriculture is
responsible for ensuring that all provisions of this
specific exemption are met. It is also responsible for
providing information in accordance with 40 Code of
Federal Regulations (CFR) 166.32. Accordingly, a report
summarizing the results of this program must be
submitted to EPA Headquarters and the EPA Region 9
office no later than six months from the date of
issuance or prior to requesting another sp-ecinc
exemption for this use.
2. Caffeine is an unregistered chemical. There are no
enduse products registered containing caffeine. The
State of Hawaii proposes use of a soluble powder
containing 99-100% caffeine supplied by EastWest United
Group, Inc. The Hawaii Department of Agriculture
submitted a proposed product label for use under this
emergency exemption. The following revisions must be
made to the label prior to use of this product under
this emergency exemption:
There must be a "Restricted Use
Pesticide" statement at the top of the main panel
of the label that reads:
"Restricted Use Pesticide
Due to High Acute Toxicity and Potential Hazard
to Applicators
For retail sale to and use only by Certified
Applicators or persons under their direct supervision
and only for those uses covered by the Certified
Applicator's certification."
The proposed label lacks an ingredient statement.
Such a statement is required and should appear on the
front of the label. The ingredient statement should
read:
Active ingredient
Caffeine .......................... 99 %
Inert Ingredient............................. 1 %
Total .................................
100 %
A signal word must be put on the front of the
label which must read:
WARNING (AVISO).
The directions for use must include the following
statement:
"AGRICULTURAL USE REQUIREMENTS:
DIRECTIONS FOR USE:
For early entry to treated areas that is
permitted under the Worker Protection Standard and that
involves contact with anything that has been treated,
such as plants, soil, or water, wear: coveralls over
long-sleeved shirt and long pants, socks and chemical
resistant footwear, goggles or face shield, and
waterproof gloves."
Based on the toxicity and pharmacological effects
of caffeine as reported in the literature, labeling must
indicate that the following groups, in particular,
should not be exposed to either the spray or its
residues:
pregnant women,
toddlers and infants under the age of 2,
children taking medications for asthma or
attention-deficit disorder,
individuals with a history of heart disease, high
blood pressure, or circulatory problems.
Taking into consideration the unknown persistence
of residues, the pharmacological effects of caffeine,
and the groups of individuals at risk, the following
modifications must be made regarding Sites of
Application:
Applications to turf or lawns are prohibited.
Caffeine may be applied to floriculture and
nursery crops, outdoor ornamental plants in residential
areas, parks, hotels and resorts, and forest habitats.
The proposed labeling is somewhat confusing in
that it appears to direct the use of eye protection
(goggles, face shield or full face respirator) and the
use of respiratory protection in the form of an approved
dust-mist respirator. If an approved full face
respirator is used, a dust-mist respirator cannot be
used. The use of a dust-mist respirator may be combined
with the use of goggles or a face shield. Therefore, the
Personal Protective Equipment (PPE) section should be
revised to read:
"Applicators and other handlers must use the
following PPE:
Coveralls over long-sleeved shirt and long pants,
chemical resistant footwear plus socks, waterproof
gloves, protective eyewear (goggles or face shield) and
a dust-mist filtering respirator (MSHA/NIOSH approval
number prefix TC-21C) or a full-face respirator "
The PRECAUTIONARY STATEMENTS must be revised to
read:
"May be fatal if swallowed or inhaled. Causes
substantial but temporary eye injury or skin irritation.
Harmful if absorbed through skin. Do not get in eyes, on
skin or on clothing. Do not breathe dust. For handling
activities, use dust/mist filtering respirator (MSHA/NIOSH
approval number prefix TC-21 C), or a NIOSH approved
respirator with any N, P, R, or HE prefilter. Wear
coveralls worn over long-sleeved shirt and long pants,
socks and chemical resistant footwear, goggles or face
shield and waterproof gloves. For Cleaning Equipment:
Add a chemical resistant apron."
The First Aid section must read:
"IF SWALLOWED; Call a poison control center
or doctor immediately for treatment advice. Have person
sip a glass of water if able to swallow. Do not induce
vomiting unless told to by a poison control center or
doctor. Do not give anything by mouth to an unconscious
person.
IF ON SKIN OR CLOTHING: Take off contaminated
clothing. Rinse skin immediately with plenty of water
for 15-20 minutes. Call a poison control center or
doctor for treatment advice.
IF INHALED: Move person to fresh air. If person
is not breathing, call 911 or ambulance, then give
artificial respiration, preferably mouth-to-mouth, if
possible. Call a poison control center or doctor for
further treatment advice.
IF IN EYES: Hold eye open and rinse slowly and
gently with water for 15-20 minutes.
Remove contact lenses, if present, after the
first 5 minutes, then continue rinsing eye.
Call poison control center or doctor for
treatment advice."
A statement must be added to the label that
reads:
"NOTE TO PHYSICIAN: Probable mucosal damage
may contraindicate the use of gastric lavage."
Additionally, the following statements are
suggested types of information that may be included in
the Note to Physician, if applicable:
technical information on symptomatology;
use of supportive treatments to maintain life
functions;
medicine that will counteract the specific
physiological effects of the pesticide;
company telephone number to specific medical
personnel who can provide specialized medical advice.
A "USER SAFETY RECOMMENDATIONS" section
must be added to the label that
reads:
"Wash hands before eating, drinking, chewing
gum, using tobacco or using the toilet.
Remove contaminated clothing and wash clothing
before reuse."
Treatments to any site including outdoor
ornamental plants in residential areas, parks, hotels
and resorts can not be accessible to the general public
and must be sealed off and restricted for at least 24
hours following spraying. Therefore the re-entry
statements must be revised to read:
Treated areas are not to be entered for at
least 24 hours following spraying."
3. Caffeine
may be applied at 100 - 200 pounds of caffeine in 1200
gallons of water per acre.
Six applications per acre per year may be made at
the maximum application rate. If a lower rate is used
more applications may be made but shall not exceed a
maximum of 1200 pounds of caffeine per acre per year.
4. Applications
can be made with ground equipment only.
Aerial applications or by chemigation is
prohibited.
5. A total of 2000 acres may be treated throughout
Hawaii.
6. Applications
must be made by or under the direct supervision of a
certified applicator.
Treatments to any site including outdoor
ornamental plants in residential areas, parks, hotels
and resorts can not be accessible to the general public
and must be sealed off and restricted for at least 24
hours following spraying, A 24 hour re-entry period is
required for all areas treated.
7. Applications
made in accordance with the above provisions are not
expected to result in residues of caffeine in or on food
crops. Therefore, no time-limited tolerances will be
established to support this emergency exemption.
8. There-is
great uncertainty regarding the risks to non-target
organisms resulting from the application of caffeine to
control coqui and greenhouse frogs. The only toxicity
information submitted by the State is for acute
lethality and chronic toxicity in mammals. Based on this
information, applications could present considerable
acute and chronic risk to directly and indirectly
exposed mammals. Very limited toxicity information is
available for an assessment of the risk caffeine may
present in the terrestrial environment. No acute or
chronic toxicity data were presented for aquatic
organisms, aquatic and terrestrial plants, birds, and
terrestrial invertebrates, nor were any found in the
scientific literature. This does not allow a full
assessment of risk for those organisms. Some ad-hoc
observations were presented that indicate caffeine is
lethal to terrestrial invertebrates (snails).
Considering caffeine toxicity to mammals and amphibians,
it is likely to affect other terrestrial organisms as
well. In addition, although caffeine has a short aquatic
half-life, it is unclear if significant risk is present
for aquatic organisms since no aquatic toxicity
information was presented.
Two major areas of uncertainty
regarding caffeine use need to be addressed. First is
the potential effect caffeine may have on non-target
organisms. Since very little information exists
regarding caffeine hazard to non-mammalian species,
systematic monitoring studies for affected non-target
organisms, including insects, birds, mammals, reptiles,
and amphibians, need to be conducted in and around areas
of caffeine use. Effects on behavior and survival should
both be noted. Accurate data, including the number and
species of effected organisms, should be recorded. Dead
and moribund organisms found near areas of caffeine use
should be collected, placed into individual chemically
clean containers, labeled, frozen, and shipped to a
qualified analytical laboratory where whole body
caffeine residues can be determined.
The second area of uncertainty is
the effectiveness with which caffeine will address the
purpose for which it is used. Systematic studies to
determine efficacy should be conducted in concert with
studies of non-target organism impacts. These studies
should address pre and post application frog densities
at application sites taking into account time-dependent
population density recovery. They should also address
the control program's ability to prevent frog
population emigration.
This information must be submitted if an emergency
exemption request for use of caffeine under FIFRA
Section 18 is submitted to the Agency in the future. The
state may contact Dr. Tim Bargar at (703) 605-1531 if
there are specific questions about the requirements of
the monitoring program or efficacy studies.
9. The United States Department of Interior, Fish and
Wildlife Service, Pacific Islands Ecoregion sent a
letter, dated June 20, 2001, to the Hawaii Department of
Agriculture indicating that the endangered Hawaiian
hoary bat (Lasiurus cinereus semotus) may be present at
application sites, such as Lava Tree and Kalopa State
Parks on the island of Hawaii, but the application
method is not likely to expose bats to caffeine.
However, since non-target mortality to snails and slugs
was noted the proposed label specifically excludes
application 'in habitats of the endangered Oahu Tree
Snails' (Achatinella spp.). Additionally, if application
of caffeine is proposed, for any habitats containing
threatened and endangered plants, invertebrates, or any
species proposed for listing, the Hawaii State
Department of Agriculture must contact the United States
Department of Interior, Fish and Wildlife'Service,
Pacific Islands Ecoregion prior to treatment.
10. The EPA Headquarters and Regional office shall be
immediately informed of any adverse effects or misuse
resulting from me use of this pesticide in connection
with this exemption.
11. This specific exemption will expire one year from the
date of issuance.
Any future correspondence in
connection with this exemption should refer to file
symbol Ol-HI-03. If you have any further questions
regarding this issue, please do not hesitate to contact
Barbara Madden, of my staff, at (703) 305-6463 or by
e-mail at Madden. Barbara@epa.gov.
James J. Jones
Deputy Director for Pesticide Programs
Office of Pesticide Programs
cc:
U.S. EPA Region 9
Glenda Dugan
Phone: 415-744-1066
State Health Offical
Hawaii Department of Health
1250 Punchbowl Street
PO Box 3378
Honolulu, HI 96801
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